Technical Services Specialist - Downstream

Team Horizon is seeking a Technical Services Specialist - Downstream  for our client based in Dublin. The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS).

The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Downstream manufacturing.  The Technical Specialist will be responsible for providing support for new/existing drug substance (DS) manufacturing processes at the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. 

The position is accountable for timely completion of commercial sustaining and technical transfer related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• Excellent contracting rates on offer

What you will be doing:

• To provide process expertise in Downstream purification process: buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.


• To author and review process technical documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents


• To lead or support the continuous process verification program at ADMF


• To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements


• To support the changes in raw materials and consumables


• To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines


• To identify and implement process improvements, e.g. yield, cycle time reduction


• To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale


• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.


• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution


• Lead any key process changes using change control system


• Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits


• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations


• To author and review common technical document (CTD) sections and reports for regulatory agency submissions


• To serve as a subject-matter expert (SME) on downstream purification process  and support during regulatory agency inspections.

What you need to apply:

• Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization


• Technical and operational knowledge of multiple unit operations in cell culture processing


• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing


• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings


• Ability to present and defend technical and scientific approaches in both written and verbal form


• Ability to drive for results independently and adapt to rapidly changing priorities


• Experience of Technology Transfer activities is advantageous


• Knowledge or experience of start-up or systems would be ideal


• Detail orientated


• Technical writing competency